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- Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterolMerck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
- CDER plans new guidance on AI, electronic safety report submissions, and moreThe US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…